U.S. patent number 4,935,243 [Application Number 07/286,324] was granted by the patent office on 1990-06-19 for chewable, edible soft gelatin capsule.
This patent grant is currently assigned to Pharmacaps, Inc.. Invention is credited to Ira R. Berry, Lionel Borkan, Dilip Shah.
United States Patent |
4,935,243 |
Borkan , et al. |
June 19, 1990 |
Chewable, edible soft gelatin capsule
Abstract
In accordance with the present invention, there is provided a
chewable, edible soft gelatin capsule which comprises a shell
comprising water, gelatin, plasticizer, and an amount of
hydrogenated starch hydrolysate effective to render said shell
dispersible and soluble in the mouth of the user; and a soft
gelatin capsule fill material in which an active ingredient,
preferably a biologically-active agent, is dispersed or
dissolved.
Inventors: |
Borkan; Lionel (New Vernon,
NJ), Berry; Ira R. (Westfield, NJ), Shah; Dilip
(Flanders, NJ) |
Assignee: |
Pharmacaps, Inc. (Elizabeth,
NJ)
|
Family
ID: |
23098089 |
Appl.
No.: |
07/286,324 |
Filed: |
December 19, 1988 |
Current U.S.
Class: |
424/441; 424/451;
424/452; 424/455; 424/456 |
Current CPC
Class: |
A61K
9/0056 (20130101); A61K 9/4825 (20130101); A61K
9/4858 (20130101) |
Current International
Class: |
A61K
9/00 (20060101); A61K 9/48 (20060101); A61K
009/28 () |
Field of
Search: |
;424/441,451,452,455,456 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Robinson; Ellis P.
Assistant Examiner: Prater; P. L.
Attorney, Agent or Firm: Merchant, Gould, Smith, Edell,
Welter & Schmidt
Claims
What is claimed is:
1. A chewable, edible soft gelatin capsule which comprises:
(a) a soft gelatin shell which comprises:
about 20-45% gelatin;
about 15-30% water;
about 17.5-35% plasticizer; and
about 5-25% hydrogenated starch hydrolysate;
and wherein said shell encloses
(b) a soft gelatin capsule fill material.
2. The capsule of claim 1 wherein said plasticizer is comprised of
glycerin or sorbitol or a mixture thereof.
3. The capsule of claim 1 wherein said plasticizer is comprised of
glycerin.
4. The capsule of claim 1 wherein said fill material provides a
pharmaceutical unit dosage form of a biologically-active
substance.
5. The capsule of claim 4 wherein said biologically-active
substance comprises vitamins, minerals, or a mixture thereof.
6. The capsule of claim 4 wherein said biologically-active
substance is an antacid.
7. The capsule of claim 1 wherein said fill material is a
liquid.
8. The capsule of claim 7 wherein said fill material comprises a
vegetable oil.
9. The capsule of claim 7 wherein said fill material comprises a
liquid polyalkylene glycol.
10. The capsule of claim 1 wherein said fill material is a
solid.
11. The capsule of claim 10 wherein said fill material comprises
solid tablets or pellets.
12. The capsule of claim 1 wherein said fill material is a
semi-solid.
13. The capsule of claim 12 wherein said semi-solid comprises a
dispersion of a biologically-active agent in a mixture comprising
in major proportion a polyalkylene glycol and in minor proportion a
C.sub.2 -C.sub.4 diol or triol.
14. The capsule of claim 1 wherein said fill material comprises a
gel.
15. The capsule of claim 14 wherein the fill comprises an active
ingredient dispersed throughout a gelled polysaccharide matrix.
16. The capsule of claim 1 wherein the hydrogenated starch
hydrolysate comprises about 35-60% hydrogenated disaccharides.
17. The capsule of claim 16 wherein the disaccharides comprise a
major portion of maltitol.
18. The capsule of claim 16 wherein the hydrogenated starch
hydrolysate comprises about 0.1-20% sorbitol.
19. The capsule of claim 16 wherein the hydrogenated starch
hydrolysate comprises about 35-60% maltitol.
Description
FIELD OF THE INVENTION
The invention relates to chewable and edible soft gelatin capsules,
the shells of which comprise gelatin, water, plasticizer and a
hydrogenated starch hydrolysate.
BACKGROUND OF THE INVENTION
Pharmaceutical agents can be encapsulated in either a hard or soft
gelatin shell. Hard gelatin capsules are filled with dry materials
such as powders or time-release beadlets by introducing the
material into one section of the capsule and capping it with a
second section. The shell of a hard gelatin capsule is not
plasticized, unlike that of a soft gelatin capsule, which is
plasticized by the addition of glycerin, sorbitol, or a similar
polyol. Instead of dry materials, soft gelatin capsules generally
enclose a fluid or semi-fluid fill material or "vehicle" in which
the active ingredient is dispersed or dissolved.
Soft gelatin encapsulation of a solution or dispersion of a
pharmaceutical agent in a liquid vehicle or carrier offers many
advantages over other dosage forms such as compressed, coated or
uncoated solid tablets or bulk liquid preparations. Gelatin
encapsulation of a solution or dispersion permits accurate delivery
of a unit dose, an advantage which becomes especially important
when relatively small amounts of the active ingredient must be
delivered, as in the case of certain hormones. Such uniformity is
more difficult to achieve via a tabletting process wherein solids
must be uniformly mixed and compressed, or via incorporation of the
total dose of active ingredient into a bulk liquid carrier which
must be measured out prior to each oral administration. Soft
gelatin capsules are also more easily transported by patients than
bulk liquids, since only the required number of doses need be
removed from the package.
Soft gelatin encapsulation further provides the potential to
improve the bioavailability of pharmaceutical agents. Relatively
insoluble active ingredients can be dispersed in a liquid or gelled
carrier to provide faster absorption upon rupture of the capsule.
For example, Miskel et al. (U.S. Pat. No. 3,851,051) disclose soft
gelatin capsules which contain aqueous solutions or suspensions of
active ingredients in a water-soluble gel lattice matrix which is
formulated to rapidly disperse upon rupture of the capsule
shell.
A well-recognized difficulty in the art of soft gelatin
encapsulation is that the gelatin capsule shell can be
deleteriously effected by water or other aqueous solvents present
in the capsule fill material. One way in which previous
investigators have addressed the problem of the delivery of an
aqueous fill material in a water soluble capsule shell has been by
modifying the composition of the shell. For example, the shells of
soft gelatin capsules have been modified in order to produce an
increased stability of the shell to withstand dissociation by an
aqueous capsule fill material. Szymanski et al. (U.S. Pat. No.
3,865,603) disclose gelatin compositions which are "extended" by
adding to the gelatin of the shell fluidity starches and thermally
modified starches, both of which are chemically modified by the
addition of monoreactive moieties.
Kreuger (U.S. Pat. No. 2,580,683) discloses the addition of
non-hygroscopic water soluble substances (i.e., substances whose
physical characteristics will not be appreciably altered by the
effects of water vapor) to the shell of gelatin capsules which have
been filled with aqueous solutions of an ingredient compounded with
a hygroscopic substance. Sugars are disclosed as the preferred
non-hygroscopic constituent of the capsule wall. Raising the sugar
content of the capsule wall is disclosed as a means of reducing the
required content of dry material in the fill.
Morishita (Japanese Application No. 56-89833) discloses a shell
material formed from gelatin, tannic acid, water, and "sugar-type
ethyl alcohol, grape sugar, or a similar sugar." Morishita further
discloses that this acidic shell encloses a non-acidic filler.
Kobayashi (U.S. Pat. No. 730,926) discloses a soluble, filmy
substance used as a wrapper for medicines, either powders or pills,
which comprises isinglass or gelatin, starch, and water. A film of
"substantially equal parts" of starch and gelatin is disclosed
which is made of edible ingredients, and which is soluble in saliva
or gastric juice. The film disclosed by Kobayashi is used by
wrapping it around medicines, and then putting the wrapped medicine
in water, so that the film swells and softens.
The soft gelatin-based compositions commonly employed to form the
shells of soft gelatin capsules are not palatable or edible as
those terms are understood in the art. Although they are not toxic,
most shells yield a gummy, unpleasant tasting, intractable mass in
the mouth if they are chewed. However, a gelatin shell which is
chewable and edible in the sense that it is pleasant tasting and
can be readily fragmented, dissolved, and swallowed would be
advantageous for a number of reasons.
For example, in instances where a user is in medical distress from
the sudden attack of a condition such as angina pectoris, rapid
release of the active ingredient in the fill material of a capsule
into the mouth is essential. The shell of a capsule must dissolve
rapidly, without leaving any intractable, insoluble residue in the
mouth upon which the distressed user might choke. Additionally,
when the active ingredients are palatable and thus need not be
swallowed whole, soft gelatin capsules provide a convenient
delivery vehicle for a unit dosage of the active ingredient.
Children and elderly users may not be able to swallow entire
capsules, tablets, or pills. Soft gelatin capsules allow these
users to easily chew and ingest the active ingredients within the
capsules in a palatable form.
Therefore, a need exists for a soft gelatin capsule comprising a
shell which is readily chewable and edible.
BRIEF DESCRIPTION OF THE INVENTION
The present invention provides a chewable, edible soft gelatin
capsule which comprises:
(a) a soft gelatin shell which comprises about 20-45% gelatin;
about 15-30% water; about 17.5-35% plasticizer; and about 5-25% of
a hydrogenated starch hydrolysate; and wherein said shell
encloses
(b) a soft gelatin capsule fill material.
Preferably the soft gelatin capsule of the invention provides a
pharmaceutical unit dosage form of a biologically active substance
such as a drug, a mineral, or a vitamin. However, the capsule may
also provide a means to deliver a confection, a breath-freshener,
or a similar non-toxic ingestible material.
As used herein, the term "soft gelatin capsule fill material" is
intended to mean a substantially water-free material (less than or
equal to about 5-7% water) which includes at least one active
compound and optional amounts of co-solvents, buffers, surfactants,
thickeners, and the like. The fill material may be of solid,
semi-solid, gel, or liquid form, so long as it is compatible with
soft gelatin encapsulation, i.e., it does not substantially degrade
the soft gelatin shell.
Unless otherwise indicated, all percentages given herein are
percentages by weight of the gelatin shell.
DETAILED DESCRIPTION OF THE INVENTION
In accordance with the present invention, there is provided a
chewable, edible soft gelatin capsule which comprises a shell
comprising water, gelatin, plasticizer, and an amount of
hydrogenated starch hydrolysate effective to render said shell
dispersible and soluble in the mouth of the user; and a soft
gelatin capsule fill material in which an active ingredient,
preferably a biologically-active agent, is dispersed or
dissolved.
Soft Gelatin
The starting gelatin material used in the manufacture of capsules
is obtained by the partial hydrolysis of collagenous material, such
as the skin, white connective tissues, or bones of animals. Type A
gelatin is derived mainly from porcine skins by acid processing,
and exhibits an isoelectric point between pH 7 and pH 9, while Type
B gelatin is derived from alkaline processing of bones and animal
(bovine) skins and exhibits an isoelectric point between pH 4.7 and
pH 5.2. Gelatin may also be derived from the skin of cold water
fish. Blends of Type A and Type B gelatins can be used to obtain a
gelatin with the requisite viscosity and bloom strength
characteristics for capsule manufacture. Gelatin can be obtained
from the Sigma Chemical Company, St. Louis, Mo. For a general
description of gelatin and gelatin-based capsules, see Remington's
Pharmaceutical Sciences, 16th ed., Mack Publishing Company, Easton,
Pa. (1980), page 1245 and pages 1576-1582.
The shell of the present capsule comprises about 20-45%, preferably
23-41%, and most preferably about 28-36% of gelatin. The gelatin
may be of Type A, Type B, or a mixture thereof. Bloom numbers, the
indicator of gelatin strength, may range from about 60-300.
The starting gelatin material of the present capsule is modified to
produce "soft gelatin" by the addition of a plasticizer to the
gelatin. The addition of plasticizer is necessary in order to
achieve the softness and flexibility of the capsule shell required
for chewability. Useful plasticizers of the present invention
include glycerin (1,2,3-propanetriol), D-sorbitol (D-glucitol), or
similar low molecular weight polyols. Glycerin and D-sorbitol may
be obtained from the Sigma Chemical Company, St. Louis, Mo. The
shell of the present capsule comprises about 17.5-35%, preferably
19-31%, and most preferably about 22-28% of plasticizer. The
preferred plasticizer of the present invention is glycerin.
Water
The shell of the present soft gelatin capsule comprises about
15-30%, preferably about 17-29%, and most preferably about 20-26%
of water. The water content of the shell aids in its rapid
dissolution upon contact with saliva and other gastric fluids
present in the mouth.
The amount of water contained in the present capsule shell is in
contrast with the higher water content employed in Krueger (U.S.
Pat. No. 2,580,683), which discloses capsule shells of gelatin,
sugar and a minimum of about 34% water. A shell composition of
about 45% water is also disclosed by Krueger. Similarly, Morishita
(Japanese Application No. 56-89833) discloses a capsule shell
comprising about 44% water.
Hydrogenated Starch Hydrolysate
In order to augment the taste and chewability of the capsule shell,
as well as to assist in the rapid dissolution of the shell upon
chewing, the present capsule shell further comprises a hydrogenated
starch hydrolysate.
Hydrogenated starch hydrolysates useful in the present shell
include those which contain less than 3% of polyols whose degree of
polymerization (DP) is higher than 20, about 35-60% of maltitol (DP
2), about 0.1-20% of sorbitol (DP 1), and the balance being
constituted by a mixture of polyols of DP 3 to 20. Preferably, the
hydrolysates are characterized by a content of lower than 1.5% of
polyols whose DP is higher than 20, 5-8% of sorbitol, 50-53% of
maltitol, and the balance being constituted by a mixture of polyols
of DP 3 to 20. The raw starch material selected for hydrolysis may
be any type of starch; for example, potato starch, manioc starch,
wheat starch, and the like may be utilized.
The hydrogenated starch hydrolysates useful in the present shell
are prepared by a two-step method. First, a starch "prehydrolysate"
of dextrose (D-glucose) equivalent of 10-35 is subjected to partial
hydrolysis which is enzymatically catalyzed by at least the action
of a .beta.-amylase. Hydrolysis is continued until the dextrose
equivalent of the resulting starch hydrolysate is brought to a
value of 45-53. When the original prehydrolysate has a dextrose
equivalent of 10-27, the supplementary enzymatic action of
.alpha.-amylase is also included in the hydrolysis step. At the
completion of the hydrolysis step, the starch hydrolysate is in the
form of a syrup which comprises D-glucose (dextrose),
disaccharides, tri- to hexasaccharides, for example, maltose and
sucrose, and saccharides higher than hexasaccharides.
In a second preparation step, the starch hydrolysate is
hydrogenated in order to produce sugar alcohols. The hydrogenation
is continued until a reducing sugar content of less than about
0.2%, and preferably less than about 0.1%, is attained by the Raney
nickel method, i.e., by high pressure hydrogenation similar to
glucose hydrogenation. The hydrolysate is introduced into a
hydrogenation reactor after purification with activated carbon and
resins and following concentration until a dry matter content of
about 37-40%. The hydrogenation takes place in the presence of a
Raney nickel catalyst, at a temperature of about
100.degree.-150.degree. C. and under a hydrogen pressure of about
40-70 kg/cm.sup.2, and is brought to a close after a reaction time
of about 2-4 hours. The catalytic agent constituted by the Raney
nickel is separated from the hydrogenated hydrolysate by
decantation. Successively, the hydrogenated hydrolysate is
introduced into a conical decanting device, filtered in order to
remove the ultimate traces of catalytic agent, demineralized on
cationic and anionic resins, and evaporated until the desired dry
matter content is obtained. At the completion of these steps, the
finished product is in the form of a colorless, odorless, clear
syrup with a pleasant sweet taste and no aftertaste. The
hydrogenated starch hydrolysate is non-cariogenic (i.e., does not
cause tooth decay), and is of high organic and mineral purity. Its
viscosity is about 1500-2100 centipoises, measured at 20.degree. C.
with a concentration of about 74% dry matter.
One commercially-available hydrogenated starch hydrolysate
comprises the following, on a dry basis: about 0-3% hydrogenated
saccharides with degree of polymerization greater than 20; about
6-8% D-sorbitol (D-glucitol), the sugar alcohol produced by the
hydrogenation of glucose in the starch hydrolysate; about 50-55%
hydrogenated disaccharides, primarily maltitol, the sugar alcohol
produced by the hydrogenation of maltose; and the balance being
constituted by a mixture of polyols of DP 3 to 20. Based on this
carbohydrate profile, the average molecular weight of this product
is about 630. Its pH in solution is from about 5 to 7. The
refractive index is from about 1.4760-1.4830.
A hydrogenated starch hydrolysate is present in the shell of the
present soft gelatin capsule in a weight percentage of about 5-25%,
and preferably from about 18-22%. It has been discovered that the
presence in the capsule shell of the hydrogenated starch
hydrolysate in these amounts augments the chewable and palatable
properties of the shell, as well as assists in its rapid
dissolution upon chewing. Unlike the soft gelatin capsule disclosed
by Ebert et al. (U.S. Pat. No. 4,428,927), in which the presence of
a natural or synthetic masticatory substance in the capsule shell
insures that an insoluble residue is left in the mouth which does
not change significantly in size upon continued chewing, the
presence of the hydrogenated starch hydrolysate in the present
capsule shell ensures that the shell will quickly dissolve as it is
chewed. This quick-dissolving property makes the present capsule
particularly effective for administration of medicines or other
biologically-active substances to persons in medical distress, to
the elderly, to children, or to animals, all of whom may not be
able to swallow a hard capsule or to chew a soft capsule for a
prolonged period. In addition, the pleasant, sweet taste imparted
by the hydrogenated starch hydrolysate makes the present capsule
more palatable than capsules which are tasteless or
unpleasant-tasting.
Soft Gelatin Capsule Fill Material
The present soft gelatin capsule shell will enclose a preselected
quantity of fill material. Preferably, this enclosed fill material
will constitute a pharmaceutical unit dosage of a
biologically-active substance such as a drug, mineral, or vitamin.
The fill material of the present capsule can take one of several
forms: (i) liquid; (ii) semi-solid; (iii) solid; or (iv) gel. In
all cases, the fill material of the present capsule will contain
about 5-7% or less water so that deterioration of the aqueous shell
is minimized.
In the liquid form of the present capsule fill material, one or
more biologically-active compounds can be dispersed or dissolved in
a non-toxic liquid base. Preferably the liquid base of the present
capsule fill material is a vegetable oil. Suitable vegetable oils
for use in the present capsule fill material include corn oil,
peanut oil, safflower oil, sunflower oil, and soybean oil. The
liquid base may also comprise a liquid polyalkylene glycol. For
example, a mixture of polyalkylene glycols having a mean molecular
weight of 200-4000, and lower alcohols having 2-8 carbon atoms and
1-3 hydroxy groups, is disclosed by Bossert et al. (U.S. Pat. No.
3,784,684). When this mixture is employed as a carrier for a
measured amount of
4-(2'-nitrophenyl)-2,6-dimethyl-3,5-dicarbomethoxy-1,4-dihydropyridine,
a known coronary dilator, and is encapsulated in a soft gelatin
capsule shell, an instant oral-release capsule is provided for
treatment of angina pectoris. Mixed with the liquid solvent base of
the present capsule may optionally be non-aqueous sweeteners such
as sodium saccharin; and non-aqueous flavorings such as cinnamon or
cinnamon oil, citric acid, lemon oil, nutmeg oil, orange oil,
peppermint oil, rose oil, spearmint or spearmint oil, and
strawberry oil.
The present soft gelatin capsule may also encapsulate a solid fill
material. Useful solid fill materials include tablets or pellets
comprising an active ingredient which can be further coated with
gelatin, sugar, and the like, as disclosed by Glassman (U.S. Pat.
No. 3,228,789).
A semi-solid fill material may also be encapsulated by the present
soft gelatin capsules. The biologically-active agent may be
dispersed in a substantially water-free carrier mixture comprising
in major proportion one or more polyalkylene glycols, preferably
comprising a mixture of a major proportion of a liquid polyethylene
glycol and a minor proportion of a waxy polyethylene glycol; and in
minor proportion a C.sub.2 -C.sub.4 diol or triol, preferably
propylene glycol. As disclosed by Shah et al. (U.S. Pat. No.
4,486,412), the active agent dispersed in the mixture is preferably
one or more basic salts, such as a magnesium, aluminum, or calcium
salt which acts as an antacid to neutralize stomach acid.
Flatulence relieving agents which are compatible with the basic
salts may also be included. Suitable flavorings and sweeteners may
also be added to the semi-solid fill material of the present
capsule to ensure the palatability of the fill.
The present soft gelatin capsules may also enclose a gel fill
comprising a gelled polymeric matrix. As disclosed by Cohen et al.
(U.S. Pat. No. 4,708,834), a polymeric matrix may be formed by
gelation of a liquid fill, following its encapsulation in a gelatin
capsule shell. The gelled fill may comprise a solution or
dispersion of an active ingredient in a polysaccharide gum, such as
a vegetable gum. The gellable fill may also include optional
amounts of cosolvents, buffers, surfactants, thickeners,
sweeteners, flavorings, and the like.
All of the fill materials discussed above may incorporate one or
more pharmaceutically-active compounds which will be present in the
fills, in amounts which may vary widely depending upon the
biological activity, and the solubility of the active compound(s).
Useful classes of pharmaceutically-active compounds which may be
delivered by the present capsules include analgesics, calcium
channel blockers, beta-blockers, antibacterials, antidepressants,
antidiabetics, anti-inflammatory agents, cerebral stimulants,
sedatives, anti-parasitics, decongestants, muscle relaxants,
anti-Parkinsonism agents, bronchodilators, and nutritional
supplements such as vitamins, minerals, fatty acids, and the
like.
The invention will be further described by reference to the
following detailed examples.
EXAMPLE I
VITAMIN C AND IRON DOSAGE FORM
A soft gelatin capsule fill composition is prepared which comprises
the following:
______________________________________ Ingredient Amount Weight
Percent ______________________________________ Ascorbic Acid 30
parts 6.0 Iron Salts 38 parts 7.6 Sodium Saccharin 1 part 0.2
Orange Flavoring 3 parts 0.6 Citric Acid 4 parts 0.8 Vegetable Oil
423 parts 84.8 ______________________________________
1. Fill Preparation
The vegetable oil is mixed with the orange flavoring, sodium
saccharin, and citric acid in a suitable vessel until a uniform
mixture results. Ascorbic acid and iron salts are subsequently
added and agitation is continued for about 45 minutes. The
resulting semi-liquid blend is then milled and degassed.
2. Shell Preparation
A soft gelatin shell is prepared which comprises the following:
______________________________________ Ingredient Amount Weight
Percent ______________________________________ Gelatin 32 parts 32
Glycerin 25 parts 25 Water 23 parts 23 Hydrogenated starch 20 parts
20 hydrolysate ______________________________________
The gelatin, glycerin, water, and hydrogenated starch hydrolysate
are added to a suitable vessel and agitated, subsequently with
heat, until a uniform melt results.
3 Encapsulation
The soft gelatin shell preparation above is employed to encapsulate
500 mg portions of the semi-liquid fill composition employing
standard encapsulation technology (#9 round die) to produce
one-piece, hermetically sealed soft gelatin capsules.
EXAMPLE II
CALCIUM DOSAGE FORM
1. Fill Preparation
A soft gelatin capsule fill composition is prepared which comprises
the following:
______________________________________ Ingredient Amount Weight
Percent ______________________________________ Calcium Carbonate
750 parts 40.0 Sodium Saccharin 1 part 0.05 Strawberry Flavoring 13
parts 0.7 Citric Acid 6 parts 0.3 Vegetable Oil 1100 parts 59.0
______________________________________
The vegetable oil is mixed with the strawberry flavoring, sodium
saccharin, and citric acid in a suitable vessel until a uniform
mixture results. Calcium carbonate is subsequently added and
agitation is continued for about 45 minutes. The resulting
semi-liquid blend is then milled and degassed.
2. Shell Preparation
A soft gelatin shell is prepared which comprises the following:
______________________________________ Ingredient Amount Weight
Percent ______________________________________ Gelatin 32 parts 32
Glycerin 25 parts 25 Water 23 parts 23 Hydrogenated starch 20 parts
20 hydrolysate ______________________________________
The gelatin, glycerin, water and hydrogenated starch hydrolysate
are added to a suitable vessel and agitated, subsequently with
heat, until a uniform melt results.
3. Encapsulation
The shell preparation above is employed to encapsulate 1870 mg
portions of the semi-liquid fill composition employing standard
encapsulation technology (#20 round die) to produce one-piece,
hermetically sealed soft gelatin capsules.
When ingested and chewed, the capsules of Examples I and II readily
rupture to release their contents in the mouth of the user. The
capsule shell quickly dissolves so that it can be swallowed along
with the capsule fill material. No sticky or gummy residue remains
in the mouth of the user after a few seconds of chewing. Both the
shell and the fill yield a pleasant taste and mouthfeel when
ingested in this manner.
While certain representative embodiments of the invention have been
described herein for purposes of illustration, it will be apparent
to those skilled in the art that modifications therein may be made
without departing from the spirit and scope of the invention.
* * * * *